FDA clears Anulex's fiXate Tissue Band System to treat chronic trunk/limb pain

Anulex Technologies, Inc., a privately held medical device manufacturer, has announced the U.S. Food and Drug Administration (FDA) clearance to market the fiXate™ Tissue Band product, designed to secure Spinal Cord Stimulation (SCS) lead anchors to the fascia or interspinous/supraspinous ligament in patients with chronic, intractable pain of the trunk and/or limbs.

The Anulex Technologies fiXate™ Tissue Band provides more consistent SCS lead anchor securement by offering a novel delivery system that facilitates efficient fixation to the surrounding tissue. The fiXate™ Tissue Band System is compatible with most commercially available spinal cord stimulation lead anchors.

Dr. Richard Bowman from the Center of Pain Relief in West Virginia had this to say after performing the first fiXate™ Tissue Band case: "This product addresses a need physicians have raised, enhancing confidence in the consistency of Spinal Cord Stimulation lead fixation while reducing procedure times." Jeff Peters, Anulex's Executive Chairman, goes on to say, "with the clearance of the fiXate Tissue Band, Anulex continues to demonstrate its commitment to developing novel and clinically relevant solutions for soft tissue fixation and repair."

Source: Anulex Technologies, Inc.